Lung DiseasesNCT00006306
Effects of Chronic Ozone Exposure on Lung Function
An observational study of Lung Diseases and Lung Diseases, Obstructive, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine the effects of chronic ozone exposure on lung function in young men and women. Read more about this study
- Who is it for?
- Ages 18 to 21 years
- Conditions the study is for
- Lung Diseases, Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 1999to Aug 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 21 years
- All sexes
- No healthy volunteers
- Adult
No eligibility criteria
About this study
To determine the effects of chronic ozone exposure on lung function in young men and women.
Read the detailed description
BACKGROUND:
A large part of the U.S. population is exposed to ambient ozone (O3) concentrations that are associated with acute respiratory health effects; however, little is known about the effects on human respiratory health of long-term exposure to such ambient concentrations. Chronic exposure of non-human primates to high concentrations of O3 are associated with pathologic changes in the centriacinar region of the lung that are similar to changes observed in young cigarette smokers. This is the first detailed epidemiologic study of the effects of chronic exposure to an air pollutant based on individual estimates of lifetime exposure and controlled exposure data. The study tests a specific toxicologic model in humans that has relevance for chronic respiratory disease and explores mechanisms of effects.
DESIGN NARRATIVE:
The study tested the hypothesis that, in humans, there was an exposure-response relationship between the amount of chronic exposure to ambient O3 and measures of lung function that reflected changes in the centriacinar region of the human lung (FEF25-75); and this relationship was not seen with measures of more proximal airway function (FEV1). First-year UC Berkeley students, ages 18-21 yrs, who were lifelong residents of the Los Angles Basin, (high O3) and the San Francisco Bay Area, (low O3) were studied. Lifetime exposure to ambient O3 was estimated with methods developed by the investigators that combined questionnaire and ambient O3 data. Lung function was assessed with maximum expiratory flow-volume curves. Students were studied after 4-6 months of low ambient O3 exposure and immediately after 2-3 months of exposure to summertime O3. Students from each area who were at the upper and lower tails of the FEF25-75 distribution underwent two controlled O3 exposures (seasonal as above) followed by bronchoalveolar lavage/biopsy to evaluate relationships between measures of inflammation, injury/repair and oxidant induced damage/repair and FEF25-75. Regression was used to evaluate relationships between lifetime O3 exposure and lung function, adjusted for past and family respiratory history, allergy history, home characteristics, exposure to environmental tobacco smoke and particle air pollution and NO2.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Medical subject headings
- Lung Diseases, Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2000 (estimated)
- Study startSep 1999
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Ira Tager, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006306
- Sponsor's protocol ID
- 134
- Other IDs
- R01HL060689
- Status last verified
- Jan 2006
- First submitted
- 28 Sep 2000
- Last updated
- 29 Feb 2016
- Results posted
- No
Publications
Tager IB, Balmes J, Lurmann F, Ngo L, Alcorn S, Kunzli N. Chronic exposure to ambient ozone and lung function in young adults. Epidemiology. 2005 Nov;16(6):751-9. doi: 10.1097/01.ede.0000183166.68809.b0.
PubMed 16222164
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chronic Ozone Exposure on Lung Function
- ClinicalTrials.gov ID
- NCT00006306
- Acronym / sponsor ID
- 134
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 1999
- Study completion
- Aug 2004 (actual)
- First posted
- 29 Sep 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the effects of chronic ozone exposure on lung function in young men and women.
Detailed description
BACKGROUND:
A large part of the U.S. population is exposed to ambient ozone (O3) concentrations that are associated with acute respiratory health effects; however, little is known about the effects on human respiratory health of long-term exposure to such ambient concentrations. Chronic exposure of non-human primates to high concentrations of O3 are associated with pathologic changes in the centriacinar region of the lung that are similar to changes observed in young cigarette smokers. This is the first detailed epidemiologic study of the effects of chronic exposure to an air pollutant based on individual estimates of lifetime exposure and controlled exposure data. The study tests a specific toxicologic model in humans that has relevance for chronic respiratory disease and explores mechanisms of effects.
DESIGN NARRATIVE:
The study tested the hypothesis that, in humans, there was an exposure-response relationship between the amount of chronic exposure to ambient O3 and measures of lung function that reflected changes in the centriacinar region of the human lung (FEF25-75); and this relationship was not seen with measures of more proximal airway function (FEV1). First-year UC Berkeley students, ages 18-21 yrs, who were lifelong residents of the Los Angles Basin, (high O3) and the San Francisco Bay Area, (low O3) were studied. Lifetime exposure to ambient O3 was estimated with methods developed by the investigators that combined questionnaire and ambient O3 data. Lung function was assessed with maximum expiratory flow-volume curves. Students were studied after 4-6 months of low ambient O3 exposure and immediately after 2-3 months of exposure to summertime O3. Students from each area who were at the upper and lower tails of the FEF25-75 distribution underwent two controlled O3 exposures (seasonal as above) followed by bronchoalveolar lavage/biopsy to evaluate relationships between measures of inflammation, injury/repair and oxidant induced damage/repair and FEF25-75. Regression was used to evaluate relationships between lifetime O3 exposure and lung function, adjusted for past and family respiratory history, allergy history, home characteristics, exposure to environmental tobacco smoke and particle air pollution and NO2.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- 18 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
- Background: PubMed 16222164Tager IB, Balmes J, Lurmann F, Ngo L, Alcorn S, Kunzli N. Chronic exposure to ambient ozone and lung function in young adults. Epidemiology. 2005 Nov;16(6):751-9. doi: 10.1097/01.ede.0000183166.68809.b0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ira Tager
University of California, Berkeley
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases and Lung Diseases, Obstructive, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00006306, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2016.